Virtual Reality Approach in Subacromial Impingement Syndrome

NCT ID: NCT03912493

Last Updated: 2020-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-12-01

Brief Summary

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The aim of our study is to investigate the effects of game-based virtual reality exercise added to conventional physiotherapy and rehabilitation program in patients with Subacromial Impingement Syndrome (SIS). In order to evaluate its effectiveness, assessment of pain, range of motion and disability will be applied.

Detailed Description

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Subacromial Impingement Syndrome (SIS) is the result of contraction of the structures passing through the subacromial area. Problems in upper limb function in people with SIS adversely affect quality of life and functional independence of the patients. Recovery of restricted daily life functions (such as dressing, personal care, eating and body care) is one of the main goals of physiotherapy and rehabilitation in SIS and currently, conventional physiotherapy and rehabilitation methods are most commonly used. The main purpose of this method is to reduce pain, increase range of motion and muscle strength. With the developing technology various virtual reality applications have begun to take place in physiotherapy and rehabilitation programs recently. These virtual reality applications are used to motivate the patient and keep their interest in the rehabilitation. In addition, the diversity of virtual reality applications is increasing day by day so that participation of the patients and the interest in the treatment can be increased. Various measurements of the user's performance can be transferred to the clinician simultaneously with these systems. Also for most of these systems exercise modes, difficulty and duration are programmable so that the training sessions can be varied. The aim of our study is to investigate the effects of game-based virtual reality exercises added to conventional physiotherapy and rehabilitation program in patients with SIS.

Conditions

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Shoulder Impingement Syndrome Virtual Reality Rehabilitation Subacromial Impingement Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

Number of participants in this group is anticipated to be 20. Conventional physiotherapy and rehabilitation methods will be applied to this group. The conventional program includes the application of Transcutaneous Electrical Nerve Stimulation (TENS), cold pack, therapeutic ultrasound, Codman Exercises, Wand exercises, shoulder wheel exercises, finger ladder exercises, strengthening exercises with elastic band and capsule stretching.

Group Type ACTIVE_COMPARATOR

Conventional Physiotherapy and Rehabilitation

Intervention Type OTHER

The conventional physiotherapy and rehabilitation program includes the application of Transcutaneous Electrical Nerve Stimulation (TENS), cold pack, therapeutic ultrasound, Codman Exercises, Wand exercises, shoulder wheel exercises, finger ladder exercises, strengthening exercises with elastic band and capsule stretching.

Study Group

Number of participants in this group is anticipated to be 20. Participants in this group will be receiving conventional physiotherapy and rehabilitation methods and 10 minutes of exercise with the game-based virtual reality system (USE-IT). In the USE-IT system two games will be played for 5 minutes each.

Group Type ACTIVE_COMPARATOR

Game Based Virtual Reality Exercises

Intervention Type DEVICE

A game-based virtual reality device named USE-IT will be added to the rehabilitation program. USE-IT is a technological rehabilitation system designed by the Department of Physiotherapy and Rehabilitation at Hacettepe University. It is a smart gaming device which has been used in patients who suffer from movement loss in their upper extremities due to various neurological and orthopedic reasons.

Conventional Physiotherapy and Rehabilitation

Intervention Type OTHER

The conventional physiotherapy and rehabilitation program includes the application of Transcutaneous Electrical Nerve Stimulation (TENS), cold pack, therapeutic ultrasound, Codman Exercises, Wand exercises, shoulder wheel exercises, finger ladder exercises, strengthening exercises with elastic band and capsule stretching.

Interventions

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Game Based Virtual Reality Exercises

A game-based virtual reality device named USE-IT will be added to the rehabilitation program. USE-IT is a technological rehabilitation system designed by the Department of Physiotherapy and Rehabilitation at Hacettepe University. It is a smart gaming device which has been used in patients who suffer from movement loss in their upper extremities due to various neurological and orthopedic reasons.

Intervention Type DEVICE

Conventional Physiotherapy and Rehabilitation

The conventional physiotherapy and rehabilitation program includes the application of Transcutaneous Electrical Nerve Stimulation (TENS), cold pack, therapeutic ultrasound, Codman Exercises, Wand exercises, shoulder wheel exercises, finger ladder exercises, strengthening exercises with elastic band and capsule stretching.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Volunteered to participate in the study
* Aged 18-65 years,

Exclusion Criteria

* Any visual or hearing problem,
* Other neurological, orthopedic or rheumatic problems that may restrict shoulder motion or cause pain,
* Having a physical disability or uncontrolled chronic systemic disease,
* Major trauma,
* Treatment for shoulder problems within the last 6 months,
* History of epileptic attacks
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Berivan Beril KILIC, MSc, PT

Role: PRINCIPAL_INVESTIGATOR

Marmara University Institute of Health Sciences

Zübeyir SARI, Assoc Prof

Role: STUDY_DIRECTOR

Marmara University Faculty of Health Sciences

Locations

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Cadde Tıp Merkezi - Cadde Medical Center

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Dilara Merve SARI, MSc, PT

Role: CONTACT

+905333444601

Nimet SERMENLI AYDIN, MSc, PT

Role: CONTACT

Facility Contacts

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Nimet Sermenli Aydin, MSc

Role: primary

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Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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29.11.2016/36

Identifier Type: -

Identifier Source: org_study_id

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